2 devices · 2 companies · 2018 to 2019
Product code QAQ: Adjunctive Predictive Cardiovascular Indicator
2 devices under product code QAQ, 2018 to 2019, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 2 here), the regulation, and MAUDE report counts by product code.
Adjunctive Predictive Cardiovascular Indicator. 21 CFR 870.2210, Class II. The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy. MAUDE held 31 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Acumen Hypotension Prediction Index EV1000 CliK183646 · 510(k) | Edwards Lifeciences, LLC | Cardiovascular | database entry | |
| Acumen Hypotension Prediction IndexDEN160044 · De Novo | Edwards Lifesciences LLC | Cardiovascular | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.